Medical Device for use with a Stoma

ABSTRACT

An device including a proximal portion adapted for placement intermediately within a hollow body cavity to capture and divert contents; the proximal portion being expandable from an initial state with an initial diameter, into an expanded state with a diameter greater than the initial diameter for engaging the proximal portion with an inner wall of the hollow body cavity; and a distal portion, connected to the proximal portion, adapted to extend through the abdominal wall or into the intestine to conduct the hollow body cavity contents out of the proximal portion.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to provisional application Ser. No.61/450,422, filed Mar. 8, 2011.

FIELD OF INVENTION

This invention relates to a device for use in percutaneous applicationsby patients who have undergone surgery as a result of which an openingor stoma has been left in the wall of a hollow body cavity, such as anintestine, and/or in the abdominal wall.

BACKGROUND OF THE INVENTION

For patients having intestinal surgery or other operations to repair orremove a section of intestine, it is frequently necessary to perform acolostomy operation or an ileostomy operation. With a colostomy, thelarge intestine is brought through the abdominal wall, and with anileostomy, the small intestine is brought through the abdominal wall. Ineach case, an opening called a stoma is created to provide a conduit forallowing elimination of waste material from the patient's body. Drainageor discharge from the digestive system of the patient takes placethrough the opening or stoma in the abdominal wall. The body ductprotruding from the abdominal wall is typically sutured or otherwiseadhered to the skin surrounding the opening. A flexible bag or otherreceiving means is typically attached to the stoma to collect and retainliquid, solid, and gaseous waste material eliminated through the stoma.

An exemplary such procedure is illustrated in FIGS. 1A and 1B, showing aloop ileostomy 10. The stoma 14 is created by cutting the loop of theintestine protruding from the abdomen. Upstream section 13 of theintestine empties the intestinal contents through the stoma. A mucousfistula 11 is formed on the downstream end 12 of the intestine,typically blocking that section from receiving intestinal contents whilethe stoma is in place. A shunt 15 is sometimes used between the skin andthe loop of intestine.

Externalizing the intestine to form a stoma has disadvantages. It issometimes difficult to control the flow of intestinal contents and therearises a consequential risk of infection and skin irritation. Attachmentof ostomy appliances for collection of the intestinal matter can also bedifficult. Stenosis and prolapse of the intestine are additional riskswith this type of procedure.

A similar procedure might be undertaken to connect two hollow bodycavities or organs within the body, thereby allowing one organ to draininto another. For instance, a stoma, may be created in a hollow bodycavity within the body in order to allow the cavity to drain into the GItract.

SUMMARY OF THE INVENTION

Applicant has addressed the many disadvantages associated withconventional stomas by providing a device that can be utilized with astoma and, for example, eliminates the need to externalize an intestinethrough the abdominal wall. In an exemplary embodiment, the inventionprovides a device including a proximal portion adapted for placementintermediately within an intestine, or other hollow body cavity ororgan, to capture and divert contents; the proximal portion beingexpandable, optionally by using a self-expandable nitinol stent, from aninitial state with an initial diameter smaller than a diameter of theintestine for insertion of the proximal portion into the intestine, forexample, into an expanded state with a diameter greater than the initialdiameter for engaging the proximal portion with an inner wall of theintestine; and a distal portion, connected to the proximal portion,adapted to extend through the abdominal wall, or alternatively intoanother hollow body cavity or organ, to conduct the contents out of theproximal portion. In an alternative embodiment, the device also includesa valve connected to the distal portion to provide continence, allowingcontents to be selectively discharged from the distal portion. Thedevice optionally includes a transitional portion connecting theproximal portion to the distal portion. The proximal portion isoptionally compressible from the expanded state for removal of theproximal portion from the intestine or other hollow body cavity ororgan.

In alternative embodiments, the distal portion has an adjustable length,either through compression, or by removing portions of the device in acontrolled manner. The distal portion is also optionally corrugated. Thedevice may be flexible, crush resistant, and kink resistant.

In another aspect, a method of draining hollow body cavity contents isprovided comprising the steps of (a) making an incision in the GI tract;(b) making an incision into the hollow body cavity wall; (c) insertingthrough said incisions a device according to the present invention; (d)positioning said proximal portion within the hollow body cavity; (e)deploying said proximal portion to capture and divert hollow body cavitycontents; and (f) positioning said distal portion within the GI tract todrain the hollow body cavity contents out of the proximal portion andinto the GI tract.

In yet another aspect, the invention provides a method of divertingintestinal contents from an intestine without bringing the intestinethrough an abdomen comprising the steps of (a) making an incisionthrough the abdominal wall; (b) making an incision into the intestinewithout severing an entire diameter of the intestine; (c) percutaneouslyinserting through the incisions a device of the present invention; (d)positioning the proximal portion Within the intestine; (e) deploying theproximal portion to capture and divert intestinal contents; and (f)positioning the distal portion to extend through the abdominal wall toconduct the intestinal contents out of the proximal portion. Optionally,the invention includes the step of attaching a valve to the device toprovide continence allowing intestinal contents to be selectivelydischarged from the device. Further optional steps include attaching theintestine to an inner wall of the abdomen to seal the intestine, andadjusting the length of the distal portion to account for the thicknessof the abdominal wall. The invention also alternatively includes thestep of removing said device from the intestine.

DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a loop ileostomy according to the prior art.

FIG. 1B is a schematic side view of a loop ileosotmy according to theprior art.

FIG. 2 is a side view of an exemplary embodiment of the presentinvention.

FIG. 3 is a side view of another exemplary embodiment of the presentinvention.

FIG. 4 is a side view of another exemplary embodiment of the presentinvention.

FIG. 5 is a side view of another exemplary embodiment of the presentinvention.

FIG. 6 is a side view of another aspect of the present invention.

FIG. 7 is a side view of another aspect of the present invention.

FIG. 8 is a side view of another exemplary embodiment of the presentinvention.

FIG. 9 is a side view of another aspect of the present invention.

FIG. 10 is a side view of another embodiment of the present invention.

FIG. 11 is a side view of the embodiment of FIG. 10 commencinginversion.

FIG. 12 is a perspective view of the embodiment of FIG. 10 partiallyinverted.

FIG. 13 is a side view of one embodiment of the device of the presentinvention preferentially bent into a C-shape orientation.

FIG. 14 is a perspective view of the device of FIG. 13 in use.

FIG. 15 is a perspective view of another embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 2 illustrates an exemplary embodiment of a device according to thepresent invention. A proximal portion 10 of the device is disposedintermediately within an intestine 11. “Intermediately” as used hereinmeans within the length of the intestine, as opposed to at a surgicallysevered end thereof. Proximal portion 10 is adapted to capture anddivert intestinal contents from within intestine 11. The material ofconstruction for proximal portion 10 may be durable biocompatiblebarrier material that prevents leaks and allows intestinal contents topass along the internal length of proximal portion 10 without stickingto it. These attributes may be achieved by the material itself, or bycombining the material with a suitable coating. Preferably, proximalportion 10 is made of a multilayer construction of fluoropolymer, suchas expanded polytetrafluoroethylene (ePTFE). Alternative materials forproximal portion 10 include other fluoropolymers (such as FEP),polyethylene, polypropylene, polyolefins, polyimides, polyesters,silicone, fluorosilicone, and bioabsorbable materials, such as polymersand copolymers of PGA, TMC, PLA and any combination of any of thesematerials. In certain embodiments, the barrier material of the proximalportion may comprise at least one aperture therein.

Proximal portion 10 includes support structure 19. Support structure 19is preferably a self-expanding material, such as nitinol. Alternatively,support structure 19 is stainless steel or other biocompatible metal orpolymer which is expandable by the application of an external force,such as balloon-expandable materials. Also alternatively, supportstructure 19 may be formed of a polymeric material. Support structure 19may be bioabsorbable or nonbioabsorbable.

Support structure 19 may be disposed on the inside or the outside of theperimeter of distal portion 10; that is, support structure 19 may bearound the outside of the ePTFE (for example) used for the proximalportion 10, or it may be disposed inside the ePTFE used for proximalportion 10. It could alternatively be sandwiched between layers orcoatings of the material used for proximal portion 10. In any case, itis attached to the ePTFE (for example) and is used to exert an outwardforce that engages the inner wall of intestine 11 and secures proximalportion 10 in place therein, allowing intestinal contents to besubstantially fully diverted from intestine 11.

Support structure 19 enables proximal portion 10 to be expandable, froman initial state with an initial diameter smaller than the diameter ofintestine 11 for insertion of the proximal portion into intestine 11,into an expanded state with a diameter greater than said initialdiameter, for engaging the proximal portion 10 with an inner wall 12 ofintestine 11. Proximal portion 10 is also compressible from its expandedstate for removal of proximal portion from intestinal 11.

FIG. 3 illustrates an alternative embodiment of the present invention.Specifically, in FIG. 3, support structure 19 extends the length ofproximal portion 10 and beyond, extending into intestine 11 belowproximal portion 10. This structure provides for added reinforcement,and therefore patency, of intestine 11 at the stoma site. It limitstwisting or kinking of intestine 11 near the stoma site, providing thebenefit of preventing narrowing (such as by occlusion or obstruction) ofintestine 11 leading to an undesirable slowdown of intestinal flow.

FIG. 4 illustrates an embodiment of the invention in which supportstructure 19 is included in distal portion 13. The support structure canbe of the same alternative constructions as described above inconnection with proximal portion 10.

FIG. 15 depicts yet another alternative support structure 19 in whichportions along the length of the device are unsupported while regions ofboth the distal portion 13 and the proximal portion 10 are supported.

As shown in FIGS. 2-4, the device also includes a distal portion 13,connected to proximal portion 10. Distal portion 13 may be adapted toextend through abdominal wall 14 to conduct the intestinal contents outof proximal portion 10. At least distal portion 13 may be kink resistantto prevent twisting or kinking thereof. This may be done by constructingdistal portion 13 of any biocompatible material that can be made into atube. Preferably, distal portion 13 is made of ePTFE, reinforced by asupport structure similar to that described above in connection withsupport structure 19. FIG. 4 illustrates a preferred embodiment whereinthe support structure for distal portion 13 is a series of nitinolrings. Alternatively, the reinforcement can be FEP. In certainembodiments, the material of the distal portion may comprise at leastone aperture therein.

Distal portion 13 optionally has an adjustable length to accommodatedifferent width of abdominal wall 14. The adjustable length may beprovided by selection of material that is cut to size, or by use ofcorrugated or telescoping construction to facilitate compressibility orextension.

Devices of the present invention may further comprise a funnel structure(not shown) at the distal end of the device which could assist inpreventing migration or movement of the device and potentially avoidpull through of the device through the stoma.

The device of the present invention optionally includes a transitionalportion 15 connecting proximal portion 10 to distal portion 13 forattaching intestine 11 to an inner wall 16 of the abdominal wall 14. Aflange or other securing means 18 is optionally also included at theopening to connect and seal distal portion 13 to the patient's skin.

In alternative embodiments, the device of the present invention includesa valve incorporated at any point along the device, preferably the valvecould be connected to either said proximal portion 11 or said distalportion 13 for providing continence to the patient, thereby allowingintestinal contents to be selectively discharged from distal portion 13.A valve located in proximal portion 11 may provide an advantage in thatthe larger diameter of the valve opening could allow for easier passageof material and potentially reduce the risk of blockage. In anotherembodiment, a valve may be located in a proximal portion of the devicebut controlled from the distal portion.

FIG. 5 depicts an embodiment of the present invention includingretention means 51, which can be barbs or scales or the like, onproximal portion 52 for retaining device 50 in place within theintestine. Support structure 53 in this embodiment comprises nitinolstent rings that extend the entire length from proximal portion 52through and including distal portion 54. In this embodiment, device 50also includes a retention collar 55 and an iris valve 56 pneumaticallyactuated. Retention collar 55 is designed to be on the inside wall ofthe abdomen to prevent movement or migration of device 50 out of thepatient. Iris valve 56 is intended to allow a patient to have controlover the external release of intestinal contents and is designed to bedisposed outside the body.

FIG. 6 illustrates another aspect of the invention. FIG. 6 shows a dualdisc fistula collar 60. Collar 60 is preferably made from abioresorbable material that is designed to last as long as the device isintended to be in place. A more permanent device may be used, and forexample, an ePTFE scaffold can be used with the bioresorbable material.The purpose of fistula collar 60 is to anchor the inside of theintestine to the abdominal wall. This provides support for the devicethat passes through the middle of collar 60 via lumen 63. Thisfacilitates sealing of the intestine so that intestinal contents do notleak in the abdominal cavity. A retention collar (55, FIG. 5) on device50 keeps device 50 from being withdrawn into the abdominal cavity. End61 of collar 60 is designed to be placed inside the intestine, while end62 is designed to be placed against the abdominal wall. Compressioncords 64 are pulled after placement to allow accordion effect of centrallumen 63 to clamp down on device 50 and draw the intestine towards theabdominal wall.

Another aspect of the invention is illustrated in FIG. 7. FIG. 7illustrates an intestinal plug 70 which is used to seal the naturalfistula channel that remains after removal of the device. Intestinalplug 70, as with dual disc fistula collar 60, can be made from abioresorbable material, alone or with a scaffold made, for example, ofePTFE to provide strength and longer life. The dual disc fistula collar60 is left behind in vivo after removal of the device. The design ofintestinal plug 70 is similar to dual disc fistula collar 60 but withoutthe central lumen 63. End 71 of intestinal plug 70 is designed to beplaced in the intestine, and end 72 is designed to be placed against theabdominal wall. Compression cords 74 pull the two discs 71 and 72together.

FIG. 8 illustrates an embodiment of the invention in which thein-dwelling device is shown post-placement and before removal. Proximalportion 81 diverts intestinal contents. Dual disc fistula collar 82anchors the device in place. Retention collar 83 prevents the devicefrom retracting into the intestine. Iris valve 84 allows patient tocontrol release of intestinal contents. Compression cords 85 seal andpull intestine toward abdominal wall. Support structure 86 in thisembodiment is a nitinol frame which comprises a spine that creates apreferential bend in the device that helps hold it in place within theintestine but is flexible enough to allow removal of the device with aremoval sheath. Note that the bottom of the device bend is held in placeby the dual disc fistula collar 82.

FIG. 9 illustrates removal of the device according to the presentinvention. A removal sheath 90 is used to compress the device so that itcan be removed percutaneously, ideally in an outpatient setting. Removalsheath 90 is a hollow polymeric tube sized to allow the withdrawal ofthe device 91, in the illustrated embodiment, into the central lumen ofthe removal sheath 90. Removal sheath 90 is rigid enough to preventcollapse or accordioning when removing device 91. Tensioning members 92are attached to the end of device 91 (after removal of the valve) topull the stent graft into the sheath. The sheath is advanced as thetensioning members are pulled to completely capture device 91 thenremoved from the patient. FIG. 9 is an illustration of device 91 in theprocess of being retracted into sheath 90.

An alternative method of removal is demonstrated in FIGS. 10-12 whereinthe proximal end of the device can be inverted into the main channel ofthe device for ease of removal. FIG. 10 shows an embodiment of thepresent invention comprising a radial component 101 that reduces thediameter of the proximal portion 10, or at least the proximal end 103 ofthe device 100. In communication with the radial component 101 is atensioning member 102, which may be in the form of, for example, atensioning cord or retrieval line. The tensioning cord or retrieval linemay be a separate member from the radial component or may be panextended end portion of the radial component. Upon force being appliedto the tensioning member, as in FIG. 11, tension is applied to theradial component 101 which reduces the diameter of at least the proximalend of the device and anchor fins 111, positioned circumferentially onthe proximal portion and/or proximal end of the device are disengagedfrom the surrounding tissues. Once the proximal end is so reduced,additional force applied to the tensioning member 102 serves to pull theproximal end of the device into a main channel of the device and beginthe inversion process as shown in FIG. 12. The larger diameter of theproximal portion is thereby reduced.

In yet another embodiment, the device of the present invention can bepulled apart in a controlled manner in order to ease removal from theintestine or other hollow body cavity or organ. In one embodiment, tofacilitate the pull apart method the device may comprise a retrievalline that is attached directly to the proximal end of the support frame,such as a nitinol, one piece, wire frame. Pulling on the retrieval linewould pull the proximal end of the support out of the graft material.Continued tension on the retrieval line would continue to pull thenitinol wire free of the graft material in a continuous length. In oneembodiment, when enough of the wire has been pulled out that thesupported proximal region has a diameter similar to that of the stoma,the device can be removed. Alternatively, where a device comprises a onepiece nitinol wire support frame but no retrieval line is present, onecould begin pulling on the distal end of the nitinol wire. This methodwould require the user to unravel most of the device prior to removal asthe largest diameter portion of the device would be unraveled last.

As described above, the devices of the present invention may furthercomprise a preferential bending mechanism which imparts a radius ofcurvature to a region of the device, preferentially in one direction,upon expansion of the device. The region of the device capable ofachieving a radius of curvature may be located in the proximal portionof the device, the distal portion of the device or any transitionalportion therebetween. The preferential bending mechanism may be in theform of a spine along one side of a region of the device. Where thedevice comprises a support frame, an asymmetrical support frame onopposing sides could provide a suitable spine to achieve preferentialbending of the device upon expansion. As shown in FIG. 11, where thedevice comprises a support frame 53, longer apical distances 112 betweenapices 113 on adjacent stent rings along at least a region of one sideof the device could provide a spine for the device and would be asuitable preferential bending mechanism. Alternatively, the preferentialbending mechanism may be in the form of bridging members along a lengthof device connecting adjacent stent rings on one side of the devicethereby creating a spine. Alternatively, a spine could comprise an areaof denser barrier material along one side of a region of the device orany other longitudinal stiffening member. FIG. 13 shows the devicepreferentially bent along the spine 150 of the device 100 in order torender the device into a c-shape or j-shape. In FIG. 15 the spine 150 ofthe device comprises a longitudinal support structure along one side ofan otherwise unsupported region of the device which provides a suitablepreferential bending mechanism.

The preferential bending mechanism may further comprise a lockingfeature that allows the device to remain in the bent position, untilsuch time as the lock is removed or opened. One advantage to locking thedevice into a preferentially bent orientation is that the device itselfcan operate as a clamp, thereby clamping surrounding tissues andeliminating the need for supplemental anchoring means to keep the anchorin place and prevent migration. Generally, the proximal portion of thedevice would be located within a first hollow body cavity or organ andthe distal end of the device could be located in a second hollow bodycavity, suitable for receiving drainage from the first, or,alternatively, through the abdominal wall. However, the devices of thepresent invention may further be held in place by adherence to thesurrounding tissue, for example, by suturing or other means. FIG. 14shows a locked and preferentially bent device 100 in use and connectingtwo hollow body cavities or organs.

Any number of active agents, such as antimicrobials, may also beincluded as fillers or coatings in conjunction with any of theembodiments described herein.

While particular embodiments of the present invention have beenillustrated and described herein, the present invention should not belimited to such illustrations and descriptions. It should be apparentthat changes and modifications may be incorporated and embodied as partof the present invention within the scope of the following claims.

1. A device comprising: a. a proximal portion adapted for placementwithin a hollow body cavity to capture and divert said hollow bodycavity contents; at least said proximal portion being expandable, froman initial state with an initial diameter for insertion of said proximalportion into the hollow body cavity, into an expanded state for engaginghollow body cavity tissues with a diameter greater than said initialdiameter; and b. a distal portion, connected to said proximal portion,adapted to extend through a stoma in a wall of said hollow body cavityto conduct the hollow body cavity contents out of the proximal portion.2. The device of claim 1 wherein said distal portion and said proximalportion comprise at least one layer of a barrier material.
 3. The deviceof claim 2 wherein at least one of said proximal portion and said distalportion further comprise an expandable support frame with a length and achannel extending therethrough.
 4. The device of claim 1 wherein in theinitial state the device is substantially axially oriented and in theexpanded state the device comprises at least one region with a radius ofcurvature.
 5. The device of claim 3 wherein the at least one regioncomprises a preferential bending mechanism.
 6. The device of claim 4wherein the preferential bending mechanism is a longitudinal stiffeningmember.
 7. The device of claim 4 wherein the preferential bendingmechanism further comprises a locking component.
 8. The device of claim2 wherein the support frame has a substantially round cross section. 9.The device of claim 8 wherein the support frame is asymmetrical onopposing sides of said channel.
 10. The device of claim 1 wherein saidproximal portion further comprises a radial component that reduces thediameter of said proximal portion upon tensioning.
 11. The device ofclaim 9 wherein said device further comprises a tensioning member incommunication with the radial component.
 12. The device of claim 11wherein said tensioning member is oriented Within said channel andextends from said proximal portion to said distal portion.
 13. Thedevice of claim 1 wherein said proximal portion further comprises ananchoring component.
 14. The device of claim 2 wherein said membranecomprises at least one aperture.
 15. The device of claim 1 wherein thehollow body cavity is selected from an intestine, a stomach, a gallbladder, a bladder, a pseudocyst, a peritoneal cavity, and a thoraciccavity.
 16. The device of claim 1 wherein the distal portion ispositioned within the gastrointestinal tract.
 17. The device of claim 1wherein the distal portion is positioned through the abdominal wall. 18.The device of claim 1 further comprising a valve connected to saiddevice providing continence allowing intestinal contents to beselectively discharged from said distal portion.
 19. The device of claim1 further comprising a transitional portion connecting said proximalportion to said distal portion.
 20. The device of claim 1 wherein saidtransitional portion comprises a dual disk fistula collar.
 21. Thedevice of claim 1 wherein said distal portion is expandable, from aninitial state with an initial diameter into an expanded state with adiameter greater than said initial diameter.
 22. The device of claim 21wherein said proximal and distal portions are compressible from saidexpanded state for removal from the hollow body cavity.
 23. The deviceof claim 1 wherein said distal portion has an adjustable length.
 24. Thedevice of claim 1 wherein said distal portion is corrugated.
 25. Thedevice of claim 2 wherein said expandable frame is nitinol.
 26. Thedevice of claim 2 wherein said expandable frame is stainless steel. 27.The device of claim 2 wherein said expandable frame is a polymer. 28.The device of claim 2 wherein said expandable frame is bioresorbable.29. A method of diverting intestinal contents from an intestine withoutbringing the intestine through an abdomen comprising the steps of (a)making an incision through the abdominal wall; (b) making an incisioninto the intestine without severing an entire diameter of the intestine;(c) inserting through said incisions a device according to claim 1; (d)positioning said proximal portion within the intestine; (e) deployingsaid proximal portion to capture and divert intestinal contents; and (f)positioning said distal portion to extend through the abdominal wall toconduct the intestinal contents out Of the proximal portion.
 30. Themethod of claim 29, further comprising the step of including a valve onsaid distal portion to provide continence allowing intestinal contentsto be selectively discharged from said distal portion.
 31. The method ofclaim 29, further comprising the step of attaching said intestine to aninner wall of the abdomen to seal the intestine.
 32. The method of claim29, further comprising the step of adjusting the length of the distalportion to account for the thickness of the abdominal wall.
 33. Themethod of claim 29, further comprising the step of compressing saidproximal portion and said distal portion to remove said device from theintestine.
 34. The method of claim 34 wherein the device is removed fromthe intestine by inverting the device.
 35. The method of claim 29further comprising the step of removing said device from the intestineby inverting the device.
 36. The method of claim 29 further comprisingthe step of removing said device from the intestine by pulling thedevice apart.
 37. A method of draining hollow body cavity contentscomprising the steps of (a) making an incision in the GI tract; (b)making an incision into the hollow body cavity wall; (c) insertingthrough said incisions a device according to claim 1; (d) positioningsaid proximal portion within the hollow body cavity; (e) deploying saidproximal portion to capture and divert hollow body cavity contents; and(f) positioning said distal portion within the GI tract to drain thehollow body cavity contents out of the proximal portion.
 38. The methodof claim 37 further comprising the step of including a valve on saiddistal portion to provide continence allowing intestinal contents to beselectively discharged from said distal portion.
 39. The method of claim37 further comprising the step of compressing said proximal portion andsaid distal portion to remove said device from the intestine byinversion.
 40. The method of claim 39 wherein the device is removed fromthe intestine by inverting the device.
 41. The method of claim 37further comprising the step of removing said device from the intestineby inverting the device.
 42. The method of claim 37 further comprisingthe step of removing said device from the intestine by pulling thedevice apart.